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510(k) K020794

Device
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Applicant
Bayer Diagnostics Corp.
510(k) number
K020794
Product code
DKJ
Decision
Substantially Equivalent (SESE)
Decision date
2002-07-11
Date received
2002-03-11
Regulation
862.3830
Classification name
Colorimetry, Salicylate
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
KENNETH T EDDS
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DKJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093939ADVIA CHEMISTRY SALICYLATE REAGENTSiemens Healthcare Diagnostics2010-05-19
K042329SALICYLATE-SL ASSAYDiagnostic Chemicals , Ltd.2004-12-27
K014173SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATORBeckman Coulter, Inc.2002-02-15
K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULSyva Co.2001-08-13
K981872SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40Diagnostic Chemicals , Ltd.1998-06-29
K980032SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71Diagnostic Chemicals , Ltd.1998-03-02
K964715PARAMAX SALICYLATE REAGENTDade Intl., Inc.1997-04-25
K961131SALICYLATE ASSAYDiagnostic Reagents, Inc.1996-04-29
K951290AXSYM SALICYLATEAbbott Laboratories1995-08-08
K946000ABUSCREEN ONLINE(R) CALIBRATORSRoche Diagnostic Systems, Inc.1995-01-25
K904301DU PONT DIMENSION(R) SALICYLATE(SAL) METHODE.I. Dupont DE Nemours & Co., Inc.1990-11-09
K902356KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)Eastman Kodak Company1990-07-16
K882038GDS ENZYMATIC SALICYLATE REAGENTGds Technology, LLC1988-06-24
K873425EASY-TEST SALICYLATE (SAL) #16691Em Diagnostic Systems, Inc.1987-10-29
K872321EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93Em Diagnostic Systems, Inc.1987-08-28